Truliant 02-022-44-3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862305169), received between Jul 23, 2022 and Oct 3, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 25 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Insufficient Information; Joint Laxity; Pain

  MAUDE report 20359909 ↗
• InjuryJul 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 50 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19815679 ↗
• InjuryMay 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION SURGERY FOR POLYETHYLENE WEAR. THE PATIENT HAS REPORTED SEVERE PAIN, SCARRING, SWELLING, EFFUSION, ANTALGIC GAIT, INFLAMMATION, KNEE POPPING AND CRACKING, INSTABILITY, ANXIETY, EMOTIONAL DISTRESS, FUTURE SURGERIES, GENERAL DAMAGES, AND OTHER INJURIES WHICH HAVE RESULTED IN PAST AND FUTURE MEDICAL EXPENSES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Failure of Implant; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19259770 ↗
• InjuryDec 12, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, AFTER A REVIEW OF IMAGING, SURGICAL INTERVENTION WAS RECOMMENDED, AND A RIGHT TOTAL KNEE REPLACEMENT WAS SCHEDULED AND PERFORMED ON (B)(6) 2019. FOLLOWING EXTENSIVE REHABILITATION, PATIENT EXPERIENCED SWELLING AND PAIN FROM THE TOTAL KNEE REPLACEMENT THAT CONTINUES TO THIS DAY. PATIENT EXPERIENCES A SENSATION THAT THE RIGHT KNEE IS UNSTABLE, DROPS, AND DETECTS A CLICKING SENSATION. ON OR AROUND (B)(6) 2022, PATIENT RECEIVED A PHONE CALL FROM HER SURGEON WHO EXPLAINED THAT BOTH OF HER TOTAL KNEE REPLACEMENTS SYSTEMS WERE RECALLED AND INFORMED HER THAT BOTH OF HER KNEES WOULD NEED TO BE REPLACED AGAIN. PATIENT RECEIVED A LETTER (B)(6) ON (B)(6) 2022, WHICH PROVIDED WRITTEN NOTICE THAT SHE RECEIVED DEFECTIVE PARTS FROM AN EXACTECH KNEE REPLACEMENT SYSTEM AND THAT THE COMPONENTS WERE BEING RECALLED. PATIENT FOLLOWED UP WITH A VISIT TO HER SURGEON AND, UPON SURGEON¿S ADVICE AND RECOMMENDATION, SCHEDULED A CORRECTIVE RIGHT TOTAL KNEE REPLACEMENT SURGERY FOR (B)(6) 2023.

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15962020 ↗
• InjuryJul 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY EIGHT MONTHS POST INITIAL RIGHT TKA, THE FEMALE PATIENT WAS BROUGHT BACK FOR A QUAD REPAIR WITH A POLY SWAP. PATIENT RECEIVED A NEW POLY LINER. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 15090353 ↗